Wednesday, October 10, 2012

Aredia-Zometa Daubert Doubleheader

It is never a slow news day as long as Aredia-Zometa litigation is going on somewhere and as long as Joe Hollingsworth is kind enough to update us. Last week, Novartis prevailed on a Daubert motion and consequently got out on summary judgment in Luttrell v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 142816 (E.D. Wash. Oct. 2, 2012). The Luttrell case had been part of the ongoing Aredia and Zometa Multi-District Litigation. In Luttrell, the plaintiff offered the usual Aredia-Zometa allegation - that he developed osteonecrosis of the jaw (“ONJ”) as a result of his use of Aredia and Zometa to prevent or significantly delay the deep bone pain, pathologic bone fractures, and spinal cord collapse that accompany multiple myeloma. Not so usual was the usage history. The plaintiff had taken a single dose of Zometa in June 2005 and eleven doses of Aredia by June 2006. The lawsuit was filed in March 2007. The plaintiff then restarted his Aredia therapy in May 2007. By the time of dispositive motions, the plaintiff had abandoned his manufacturing defect and express warranty claims and had not provided any substantive argument in favor of his implied warranty claim, leaving only his claims for strict liability and negligent failure to warn. The court found these causes of action collapsed by the Washington Products Liability Act into a failure to warn claim that requires the plaintiff to prove cause in fact and legal cause.

The court granted the defendant's Daubert motion against the plaintiff's case-specific causation expert, Dr. Richard Jackson. Dr. Jackson purported to apply a differential diagnosis to identify the plaintiff as having Bisphosphonate-Related ONJ (“BRONJ”). The court observed that Dr. Jackson’s BRONJ diagnosis was not equivalent to an opinion that Mr. Luttrell’s BRONJ was actually caused by bisphosphonate use, calling into close question the “fit” of Dr. Jackson’s expected testimony. More crucially, the court held that Dr. Jackson failed to provide any scientific basis for how he ruled out other potential causes of Mr. Luttrell’s alleged BRONJ: “Several bald assertions buried in the transcript of a deposition as to the ‘unique’ behavior of BRONJ as compared to other causes of ONJ or other contributing factors does not qualify Dr. Jackson’s testimony as sufficiently reliable under Daubert.” The plaintiff also designated five of his treating physicians as non-retained expert witnesses. The judge concluded that the plaintiff’s reliance on statements in medical records authored by these doctors was insufficient evidence that the doctors had admissible causation opinions, particularly where several of the doctors had testified to the contrary at deposition. Moreover, the judge found the doctors to lack sufficient expertise to prove causation. Because the plaintiff lacked evidence to establish that his alleged injury was caused by Aredia and Zometa, the court granted summary judgment.

The Luttrell court also granted summary judgment on an independent basis, the plaintiff’s inability to establish warning causation, i.e., that if adequately warned of the risk his physician would have “‘take[n] a different course of action.’” After acknowledging that “[t]he legal standard for the court to remove the issue of causation from the jury is extremely high,” the court found “compelling evidence” in the fact that Dr. Brady prescribed, and the plaintiff accepted, continued Aredia therapy shortly after the plaintiff filed suit against NPC – at which point “both Dr. Brady and Luttrell were aware of the possible dangers of bisphosphonates, but still decided to use the drug.” Yes, that is something that we in the defense biz would call a Pretty Good Fact For Us. “Restarting the drug after filing the lawsuit is powerful and conclusive evidence that is incapable of a difference of opinion by any reasonable trier of fact.”

Now we go from one corner of the country, the Pacific Northwest, to the opposite corner, the Northern District of Alabama. Just two days after Luttrell, the court in NASCAR and SEC territory granted the defendant's Daubert motion against another plaintiff specific causation expert in another Aredia-Zometa MDL case, Harvey v. Novartis Pharm. Corp., No. 2:06-cv-1140-VEH (N.D. Ala. Oct. 4, 2012). In Harvey, the plaintiff alleged that his mother developed ONJ as a result of her use of Zometa. The plaintiff sought to rely upon the testimony of Dr. Jason Miller, an oral surgeon, to prove that Ms. Harvey developed ONJ due to her use of Zometa. Dr. Miller was a non-retained expert. That is, Dr. Miller was a treating physician, not an expert specially hired for litigation purposes. We have been seeing the use of non-retained experts a lot lately from plaintiffs. (Luttrell, discussed above, is another example.) Why is that? Is it cheapness? Is it laziness? Or is it a perception that non-retained, treating experts are likely to appear more credible to juries?

Whatever enhanced credibility Dr. Miller might have had, it did not cut the Daubert mustard as far as the Harvey court was concerned. The court excluded Dr. Miller’s testimony for two reasons. First, although the court recognized that Dr. Miller was an experienced oral surgeon, the plaintiff did not establish that oral surgeons in general and Dr. Miller in particular are qualified to opine on the cause of ONJ. Nothing in Dr. Miller’s credentials qualified him to offer such an opinion. Further, Dr. Miller testified that determining the cause of Ms. Harvey’s osteonecrosis was irrelevant to him because it did not affect his treatment and that his opinion about the cause of Ms. Harvey’s osteonecrosis was an assumption.

The Harvey court noted that the Sixth Circuit’s ruling in Thomas v. Novartis Pharm. Corp., 443 F. App’x 58 (6th Cir. 2011), another Aredia-Zometa case where the defendant obtained summary judgment after prevailing on its Daubert motions, was “strongly persuasive.” In Thomas, the oral surgeon has extensive training but not in determining the cause of an individual’s ONJ. The same was true in Harvey. The court rejected the plaintiff’s reliance on other judicial decisions, including one in which a court seemed to admit causation testimony from an oral surgeon based in part upon “the sincerity of the surgeon’s belief.” As the Harvey court explained, “sincerity alone is not enough to qualify an expert under Rule 702.” Hard to believe it was only after practicing law for 26 years that we learned that sincerity is a much overrated virtue.

In addition to the plaintiff’s failure to demonstrate that Dr. Miller was qualified to opine on causation, the Harvey court excluded Dr. Miller’s testimony because he did not perform a proper differential diagnosis. Specifically, Dr. Miller never ruled out osteomyelitis as the cause of the osteonecrosis: “As far as the court is aware, Dr. Miller has never offered a reason—other than his assumption—for concluding that bisphosphonate drug use, instead of osteomyelitis, caused Harvey’s osteonecrosis.” Relying on Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1253 (11th Cir. 2010), the Harvey court found that this lack of a reasonable explanation rendered the differential diagnosis unreliable and hence inadmissible.

It is possible that some of the DDL bloggers were involved in the Guinn case. It is possible that some of the DDL bloggers are being just a wee bit self-aggrandizing in mentioning the Guinn case. It is possible that by admitting that fact, we are showing how sincere we are. But, as the Harvey case shows, sincerity does not make one an expert.

We offer our sincere congrats to Joe and his team on these nice Aredia-Zometa wins. We also offer Joe congrats (perhaps with more jealousy than sincerity) on the amazing success of the Washington Nationals, while our Phillies have put away their bats and gloves and are honing their skills on the golf course.

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This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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